VIIBRYD, Vilazodone HCl Form

Vilazodone (Viibryd®) is an antidepressant. FDA Approved Indication(s) Viibryd is indicated for the treatment of major depressive disorder. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Viibryd is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Depression (must meet all):

1. Diagnosis of major depressive disorder;
   2. Age ≥ 18 years;
   3. Failure of TWO of the following, each tried for ≥ 4 weeks at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: SSRI, SNRI, bupropion, mirtazapine;
2. Dose does not exceed 40 mg (1 tablet) per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 1 of 5

   CLINICAL POLICY Vilazodone of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Depression (must meet all):

4. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 40 mg (1 tablet) per day. Approval duration: 12 months
      B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace and CP.PMN.53 for Medicaid or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration
      MAOI: monoamine oxidase inhibitor SNRI: serotonin norepinephrine reuptake inhibitor SSRI: selective serotonin reuptake inhibitor Page 2 of 5

   Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen 150-450 mg PO QAM 15-45 mg PO QHS Dose Limit/ Maximum Dose 450 mg/day 45 mg/day 20 mg PO QD
   10-20 mg PO QD
   50-300 mg PO QD
   20 mg PO QD
   20 mg PO QD
   25 mg PO QD
   40 mg/day (≤ 60 years) 20 mg/day (> 60 years) 20 mg/day
   300 mg/day
   80 mg/day
   50 mg/day
   62.5 mg/day
   50 mg PO QD
   200 mg/day
   bupropion (Wellbutrin® XL) mirtazapine (Remeron®) SSRIs citalopram (Celexa®)
   escitalopram (Lexapro®)
   Fluvoxamine® (Luvox CR®)
   fluoxetine (Prozac®)
   paroxetine (Paxil®)
   paroxetine controlled release (Paxil CR®)
   sertraline (Zoloft®)
   SNRIs desvenlafaxine (Pristiq®) duloxetine (Cymbalta®) 400 mg/day 120 mg/day 50 mg PO QD 20 mg PO BID, 30 mg BID, or 60 mg PO QD 75 mg PO BID to TID 40-120 mg PO QD venlafaxine (Effexor®) Fetzima® (levomilnacipran) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 225 mg/day 120 mg/day Appendix C: Contraindications / Boxed Warnings • Contraindication(s): Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs because of an increased risk of serotonin syndrome. • Boxed warning(s): suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors. Viibryd is not approved for use in pediatric patients. V. Dosage and Administration
   Indication Major depressive disorder Dosing Regimen 10 mg orally daily for 7 days, followed by 20 mg once daily Maximum Dose 40 mg/day VI. Product Availability
   Tablet: 10 mg, 20 mg, 40 mg Page 3 of 5

   CLINICAL POLICY Vilazodone VII.